The University of Iowa IRBs interact with other University of Iowa committees and programs that review research projects involving human subjects. None of these entities are a formal part of the University of Iowa IRB structure, but there is communication between the committees/programs regarding status of review and/or conditions of approval. The UI IRB provides some tools to help researchers learn about and obtain approval from these other entities, as necessary. The Other Committee Tool includes:
- The first graphic illustrates the relationship of these entities to the UI IRB review process. In most cases, if an IRB external to the University of Iowa is serving as the IRB of record, all University of Iowa committees must have approval in place prior to submission to the external IRB.
- The Other Committee Graphic helps researchers identify which committees need to review and approve a research project. HRPP Committee reviews occur concurrently with the IRB review. The UI HRPP strongly encourages parallel submissions to all applicable HRPP committees to prevent delays. This graphic is color coded to indicate if the committee must approve the study before the IRB review or if the committee review can be concurrent with, after or completely separate from IRB review and approval of the project.
- The HRPP Committee Regulatory Mandates includes references to the regulatory entities and laws that guide each committee.
The overall Human Research Protection Program Review process is outlined in this flowchart.
For more information about an individual review entity, click on the corresponding link below.
- Conflict of Interest in Research Committee - studies in which investigator(s) have a financial conflict
- Cooperating Schools Program - studies involving K-12 schools
- Division of Sponsored Programs/Clinical Trials Office - studies with external funding sources
- Clinical Trials Requirements for Registration with ClinicalTrials.gov
- Clinical Research Unit - studies using CRU resources
- Holden Comprehensive Cancer Center Protocol Review and Monitoring Committee - studies involving Cancer Center patients or resources
- Institutional Biosafety Committee - studies involving recombinant DNA
- Medical Radiation Protection Committee (MRPC) - studies involving ionizing radiation, radioisotopes, laser
- Nursing Research Committee - studies within the Department of Nursing
- Pathology Laboratories - studies utilizing Department of Pathology services
- Pharmacy and Therapeutics (P&T) Committee - studies involving approved or investigational drugs
- Pharmacy and Therapeutics (P&T) Investigational Drug Service (IDS) - studies involving approved or investigational drugs with a focus on drug disbursement, storage, preparation, and inventory control.
- VAMC Research and Development Committee - studies at the VAMC
- UIHC Research Billing Compliance (RBC) - Research Billing has two approval processes in which they oversee:
- Billing charges - UIHC studies that involve any of the following activity at UI Health Care, even if subjects or their insurance will not be billed for the item or service, and regardless of the study funding source (including studies with departmental or no funding)
- Procedures, tests, examinations, hospitalizations, use of Pathology services, use of clinic facilities or clinical equipment, or any patient care services, including services conducted in the Clinical Research Unit; or
- Physician services or services provided by non-physicians who are credentialed to bill (ARNPs, Physician Assistants, etc.
- CMS investigational device approval - UIHC studies with an IDE (investigational device exemption) which require approval from CMS (Centers for Medicare and Medicaid Services)
- Billing charges - UIHC studies that involve any of the following activity at UI Health Care, even if subjects or their insurance will not be billed for the item or service, and regardless of the study funding source (including studies with departmental or no funding)